MAUDE Adverse Event Report: MDT SOFAMOR DANEK PUERTO RICO MFG UNKNOWN; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number MSB_UNK_SCREW

Device Problem Malposition of Device (2616)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/30/2022

Event Type  Injury  

Event Description

Single-position oblique lumbar interbody fusion and percutaneous pedicle screw fixation under o-arm navigation: a retrospective comparative study hyung cheol kim , yeong ha jeong , sung han oh, jong min lee, chang kyu lee, seong yi , yoon ha ,keung nyun kim,and dong ah shin.Https:/ /doi.Org/10.3390/jcm12010312.Summary: the insertion of pedicle screws in the lateral position without a position change has been reported.We completed a retrospective comparison of the radiologic and clinical outcomes of 36 patients who underwent either single-position oblique lateral lumbar interbody fusion (sp-olif) using the o-arm (36 cases) or conventional olif (c-olif) using the c-arm (20 cases) for l2¿5 single-level lumbar degenerative diseases.Radiological parameters were analyzed, including screw accuracy (gertzbein-robbins classification system; grs), segmental instability, and fusion status.Screw misplacement was defined as a discrepancy of 2 mm.Clinical outcomes, including visual analog scale, oswestry disability index (odi), 36-item short form health survey (sf-36), and postoperative complications, were assessed.The spinal fusion rate was not different between the sp-olif and c-olif groups one year after surgery (p = 0.536).The odi score was lower (p = 0.015) in the sp-olif than the c-olif group.Physical (p = 0.000) and mental component summaries (p = 0.000) of the sf-36 were significantly higher in the sp-olif group.Overall complication rates, including revision, surgical site infection, ipsilateral weakness, and radicular pain/numbness, were not significantly different.Sp-olif using the o-arm procedure is feasible, with acceptable accuracy, fusion rate, and complication rate.This may be an alternative to conventional two-stage operations.Results: there were no cases of wound revision or infection in the sp-olif group.However, in the c-olif group, there was one revision case due to screw malposition.

Manufacturer Narrative

A3: 14 females and 6 male patients.This value reflects the gender of the majority of the patients reported in the article (c-olif group) as specific patients could not be identified.B3: date that the article was published.D1: brand name is unknown d4: product identifiers are unknown.G3: 510(k)# is unknown.H6: neither the device nor films of applicable imaging studies were returned to the manufacturer for evaluation.Therefore, we are unable to determine the definitive cause of the reported event.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• Brand Name: UNKNOWN
• Type of Device: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): MDT SOFAMOR DANEK PUERTO RICO MFG; barrio marianna rd 909, km0.4; humacao PR 00792
• Manufacturer (Section G): MDT SOFAMOR DANEK PUERTO RICO MFG; barrio marianna rd 909, km0.4; humacao PR 00792
• Manufacturer Contact: glen belmer ; 1800 pyramid place; memphis, TN 38132 ; 6122713209
• MDR Report Key: 17237252
• MDR Text Key: 318188480
• Report Number: 1030489-2023-00452
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MSB_UNK_SCREW
• Device Catalogue Number: MSB_UNK_SCREW
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/01/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Female